Author: Frank A. Paine
Publisher: Springer Science & Business Media
ISBN: 1461521254
Category : Technology & Engineering
Languages : en
Pages : 221
Get Book Here
Book Description
As was the case with Charles Ross's Packaging of Pharmaceuticals published by the UK Institute of Packaging in 1975 it is assumed that the reader of this book already has a broad understanding of the basics of packaging. If not the Packaging Users Handbook and the Handbook of Food Packaging are recommended. The packaging needs of pharmaceuticals are different in degree only from those of other perishable products such as processed foods. Because the required action of a medication can be nullified by any deterioration in its active principles the protection required from its packaging is at least an order of magnitude greater than that needed by foods for example. Functional efficiency is therefore of prime importance. Conversely the need for the packaging to 'sell' the medication is much less, hence the graphics required need only provide the right 'image' for the product when presented for use in hospital or surgery. Even when on sale at the pharmacy the 'appeal' required is that of providing hygiene and confidence more than anything else. Thus, the textual requirements are paramount including traceability (batch numbers, date-coding etc) in case of recall; while striking appearance to attract customer attention is in lower key. And with the increase in malicious tampering nowadays recall is more frequent.
Author: D. A. Dean
Publisher: CRC Press
ISBN: 0203301811
Category : Medical
Languages : en
Pages : 459
Get Book Here
Book Description
Pharmaceutical packaging requires a greater knowledge of materials and a greater intensity of testing than most other packed products, not to mention a sound knowledge of pharmaceutical products and an understanding of regulatory requirements. Structured to meet the needs of the global market, this volume provides an assessment of a wide range of issues. It covers the entire supply chain from conversion of raw materials into packaging materials and then assembled into product packs. Integrating information from many drug delivery systems, the author discusses testing and evaluation and emphasizes traceability and the need to for additional safeguards.
Author: Michael Richard Cohen
Publisher: American Pharmacist Associa
ISBN: 1582120927
Category : Medical
Languages : en
Pages : 707
Get Book Here
Book Description
In this expanded 600+ page edition, Dr. Cohen brings together some 30 experts from pharmacy, medicine, nursing, and risk management to provide the most current thinking about the causes of medication errors and strategies to prevent them.
Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Category : Medical
Languages : en
Pages : 517
Get Book Here
Book Description
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
Author: Dennis Jenke
Publisher: John Wiley & Sons
ISBN: 1118679474
Category : Medical
Languages : en
Pages : 400
Get Book Here
Book Description
Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.
Author: Tim Sandle
Publisher: Elsevier
ISBN: 0443216010
Category : Medical
Languages : en
Pages : 510
Get Book Here
Book Description
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386
Get Book Here
Book Description
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
Get Book Here
Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235
Get Book Here
Book Description
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Author: Vijay Kumar Thakur
Publisher: John Wiley & Sons
ISBN: 1119224462
Category : Technology & Engineering
Languages : en
Pages : 902
Get Book Here
Book Description
This unique multidisciplinary 8-volume set focuses on the emerging issues concerning synthesis, characterization, design, manufacturing and various other aspects of composite materials from renewable materials and provides a shared platform for both researcher and industry. The Handbook of Composites from Renewable Materials comprises a set of 8 individual volumes that brings an interdisciplinary perspective to accomplish a more detailed understanding of the interplay between the synthesis, structure, characterization, processing, applications and performance of these advanced materials. The Handbook comprises 169 chapters from world renowned experts covering a multitude of natural polymers/ reinforcement/ fillers and biodegradable materials. Volume 7 is solely focused on the "Nanocomposites: Science and Fundamentals" of renewable materials. Some of the important topics include but not limited to: Preparation, characterization, and applications of nanomaterials from renewable resources; hydrogels and its nanocomposites from renewable resources: preparation of chitin-based nanocomposite materials through gelation with ionic liquid; starch-based bionanocomposites; biorenewable nanofiber and nanocrystal; investigation of wear characteristics of dental composite reinforced with rice husk-derived nanosilica filler particles; performance of regenerated cellulose/vermiculite nanocomposites fabricated via ionic liquid; preparation, structure, properties, and interactions of the PVA/cellulose composites; green composites with cellulose nanoreinforcements; biomass composites from bamboo-based micro/nanofibers; synthesis and medicinal properties of polycarbonates and resins from renewable sources; nanostructured polymer composites with modified carbon nanotubes; organic–inorganic nanocomposites derived from polysaccharides; natural polymer-based nanocomposites; cellulose whisker-based green polymer composites; poly (lactic acid) nanocomposites reinforced with different additives; nanocrystalline cellulose; halloysite-based bionanocomposites; nanostructurated composites based on biodegradable polymers and silver nanoparticles; starch-based biomaterials and nanocomposites; green nanocomposites based on PLA and natural organic fillers; and chitin and chitosan-based nanocomposites.
